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AGN > SEC Filings for AGN > Form 8-K on 22-Jan-2014All Recent SEC Filings

Show all filings for ALLERGAN INC

Form 8-K for ALLERGAN INC


22-Jan-2014

Other Events


Item 8.01. Other Events.

On January 21, 2014, Allergan, Inc. (the "Company") received a notice letter dated January 14, 2014 (the "Notice Letter") from Watson Laboratories, Inc. ("Watson") stating that Watson has filed an Abbreviated New Drug Application containing a "Paragraph IV" patent certification with the U.S. Food and Drug Administration (the "FDA") seeking approval to market a generic version of the Company's Restasis® (cyclosporine ophthalmic emulsion) 0.05% product. The Notice Letter states that the "Paragraph IV" patent certification was made with respect to U.S. patent number 8,629,111 (the "'111 Patent"), covering the Company's specific formulation of the Restasis® product, which is listed in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The '111 Patent will expire in August 2024. The Company is currently evaluating the Notice Letter and intends to vigorously enforce its intellectual property rights relating to the Restasis® product, including the '111 Patent.

On January 21, 2014, the United States Patent and Trademark Office (the "USPTO") issued U.S. patent number 8,633,162 (the "'162 Patent"), covering a method of use relating to the Restasis®product. On January 21, 2014, the Company submitted the '162 Patent for listing in the Orange Book. The '162 Patent will expire in August 2024.

This report contains "forward-looking statements," including statements relating to U.S. patent numbers 8,629,111 and 8,633,162. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of the action, or inaction, of the USPTO or the FDA, and risks and uncertainties associated with litigation or other dispute resolution mechanisms, the timing of governmental actions and the protection of the Company's intellectual property rights. The Company expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risks can be found in press releases issued by the Company, as well as the Company's public filings with the United States Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. Copies of Allergan's press releases and additional information about Allergan are available at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.


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